Le Lézard
Subject: Conference

FDA Approval Process for Medical Devices 20 (London, United Kingdom - September 16-17, 2020) - ResearchAndMarkets.com


The "FDA Approval Process for Medical Devices 20" conference has been added to ResearchAndMarkets.com's offering.

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States. Participants will gain an understanding of the underlying legal and regulatory requirements and the general controls applicable to all devices, including device classification, establishment registration and device listing. With the underlying framework in mind, the approval and clearance processes for new and modified devices will be presented, including 510(k), IDE, PMA, HDE and De Novo applications. Application contents, review processes, timelines, and key guidance documents will be discussed for each major type of submission. Participants will also learn about the pre-submission process, which FDA strongly recommends to help ensure the successful submission of novel devices.

Demonstrations of how to find key information in FDA databases will be presented using participants' products and interests as examples. There will also be updates on recent legislation changes, new regulations and guidance documents.

Please note that while the law, regulations, principles and processes covered in the course apply to both medical devices and in-vitro-diagnostics (IVDs), the trainer's primary experience is with medical devices.

Benefits of attending

Upon completion of this seminar, participants will:

Agenda:

Overview of US Medical Device Regulatory Principles

Pre-Submissions

510(k) process (Premarket Notification)

De Novo Applications for Low-Moderate Risk Devices

Investigational Device Exemption (IDE) for Clinical Investigations

Premarket Approval (PMA) for Class III Devices

Humanitarian Device Exemptions

Speakers:

Jonathan Hughes

J.Hughes

Jonathan Hughes, Ph.D., FTOPRA, has over 32 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic - device combination products and in-vitro diagnostics. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.

For more information about this conference visit https://www.researchandmarkets.com/r/1oowlp



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